Search Results

The HDI 1000 system is intended for opthalmic, fetal (OB/GYN), abdominal, intraoperative (abdominal organs, vasuclar, neurological,) pediatric, small organ, musculoskeletal (conventional, superficial,) neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, and peripheral vessel indications for use.

Typical examinations shall include:

• General abdominal and pelvic studies including organ surveys and retroperitoneal cavity studies.
• Study of small parts including breasts, penis, testes, thyroid/parathyroid and the abdominal wall.
• Pediatric scans of organs. .
• Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
• Monitoring procedures for infertility applications. .
• First, second and third trimester pregnancy studies. .
• Prostate, prostate biopsy guidance, and rectal wall studies. .
• Neonatal cephalic studies. .
• Transcranial studies of middle cerebral arteries, internal carotid artery, . and vertebral arteries.
• Cardiac studies in adults and children. .
• Biopsy guidance for tissue or fluid sampling. .
• Ophthalmic studies of the eye and surrounding structures and studies to . obtain blood flow information in the eye and surrounding structures.
• Conventional and superficial musculoskeletal studies. .

This 510(k) adds the musculoskeletal applications (superficial and conventional) to the HDI 1000 system.

The HDI 1000 system is a general purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical values related to potential bioeffect mechanisms. The HDI 1000 system functions by acquiring ultrasound data and displaying it on a monitor in 2-D, M-mode, 2-D Color Flow Doppler, Color M-mode, Color Power Angio, Pulsed (PW) Doppler or in a combination of modes. An audio presentation of pulsed Doppler information is also available on the systems. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnostic purposes.

The HDI 1000 system is designed to accept a large selection of scanheads with up to two being connected to the system at any one time. The operator may select between the two scanheads by means of a control located on the system control panel. All actions affecting the performance of the scanhead are activated from the main system control panel.

The HDI 1000 system is designed to accept scanheads of the following types and frequency:
frequency range: 2.0 - 11.0 MHz
scanhead types: flat linear array, curved linear array, phased array

Specific operating conditions (frame rate, line density, center frequency, number of active elements etc.) are automatically optimized by the system software in response to user inputs such as field of view, focal depth, image quality, power etc.

This 510(k) premarket notification (K980860) concerns the Atlantis Diagnostics International, Inc. (ADII) HDI® 1000 Ultrasound System, specifically for the addition of musculoskeletal (conventional and superficial) indications for use. The submission doesn't detail a specific study with acceptance criteria and performance metrics in the typical sense for an AI/CADe device. Instead, it focuses on demonstrating substantial equivalence to predicate ultrasound devices already on the market.

For ultrasound systems, the "acceptance criteria" are generally related to demonstrating that the device performs as intended for the specified clinical applications, meets safety standards (electromagnetic compatibility, acoustic output), and has technological characteristics that are substantially equivalent to legally marketed predicate devices. The "study" proving this is implicitly the comparison presented in the 510(k) submission, alongside adherence to relevant safety standards.

Here's a breakdown based on the provided text, addressing the requested points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an ultrasound system and not an AI/CADe product, the typical performance metrics like sensitivity, specificity, or AUC are not applicable here. The acceptance criteria and performance are focused on safety, functionality, and equivalence to predicate devices, particularly regarding acoustic output and imaging modes.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not describe a clinical performance study with a "test set" in the context of imaging performance for diagnosis. The assessment for this ultrasound system focuses on engineering and safety specifications, and comparison to predicate devices.

• Sample Size: Not applicable/not specified for a typical "test set" of diagnostic images.
• Data Provenance: Not applicable. The data presented relates to device specifications and compliance with standards, not patient data for diagnostic accuracy.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. As there is no diagnostic performance test set, there is no mention of experts or ground truth establishment in this context. The "ground truth" for an ultrasound system primarily revolves around its ability to produce images and Doppler information correctly and safely based on physical principles, as demonstrated through engineering tests and comparison to established predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No diagnostic performance test set is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission is for an ultrasound imaging system, not an AI or CADe device. Therefore, no MRMC study comparing human readers with and without AI assistance would be included.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic or AI device.

7. The Type of Ground Truth Used

The ground truth used in this submission is the engineering specifications, safety standards, and established performance characteristics of legally marketed predicate ultrasound devices. The applicant demonstrates that the HDI® 1000 Ultrasound System, particularly for its new musculoskeletal indications, adheres to these technical and safety "ground truths" and is substantially equivalent to the predicate devices in its operation and output.

• Ground Truth: Engineering specifications, acoustic output limits, compliance with international safety standards (e.g., EN 60601-1, AIUM/NEMA 1992), and functional characteristics (imaging modes, transducer types, frequency range) as defined by the industry and regulatory bodies for diagnostic ultrasound equipment.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that would require a training set of data.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Ask a specific question about this device

Atlas 2.0 / Hitachi 2.0 are intended for cardiac, peripheral vascular, feval imaging and other, and ophthaimic intended uses as defined FDA guidance documents.

Typical examinations shall include:

• General abdominal and pelvic studies including organ surveys and retro-peritoneal cavity studies.
• Study of small parts including breasts, penis, testes, thyroid/parathyroid and the abdominal wall.
• Pediatric scans of organs.
• Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
• Monitoring procedures for infertility applications.
• First, second and third trimester pregnancy studies,
• Prostate, prostate biopsy guidance, and rectal wall studies.
• Neonatal cephalic studies.
• Transcranial studies of middle cerebral aneries, internal carotid artery, and vertebral . arteries.
• Cardiac studies in adults and children. .
• Biopsy guidance for tissue or fluid sampling.
• Ophthalmic studies of the eye and surrounding structures and studies to obtain blood flow information in the eye and surrounding structures.

Atlas 2.0 / Hitachi 2.0 are general purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-scroen display for thermal and mechanical values related to potential biocffect mechanisms. There function is to acquire ultrasound data and display it on a monitor in 2-D, M-mode, 2-D Color Flow Doppier, Color M-mode, Color Power Angio, Pulsed (PW) Doppier or in a combination of modes. An audio presentation of pulsed Doppler information is also available on the systems. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnostic purposes.

The Atlas 2.0 / Hitachi 2.0 systems are designed to accept a large selection of scanheads with up to two being connected to the system at any one time. The operator may select between the two scanneads by means of a control located on the system control panel. All actions affecting the performance of the scanhead from the main system control panel.

The Atlas 2.0 / Hitachi 2.0 system is designed to accept scanneads of the following types and frequency:

frequency range: 2.0 - 10.0 MHz scanhead types: fiat linear array curved linear array phased array

Specific operating conditions (frame rate, line density, center frequency, number of active clements etc.) are automatically optimized by the system software in response to user inputs such as ficld of view, focal depth, image quality, power etc.

This inquiry concerns a 510(k) Premarket Notification (K961073) for the Atlantis Atlas 2.0 / Hitachi 2.0 Ultrasound Systems, dated February 13, 1997. The document describes a general-purpose diagnostic ultrasound system.

Based on the provided text, the device is an ultrasound system and there is no mention of AI or machine learning capabilities. Therefore, the document does not contain information about acceptance criteria or studies related to AI-driven device performance. The details requested in your prompt, such as sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, would typically be found in documents pertaining to AI/ML medical devices.

The provided text focuses on:

• Device description: General purpose, mobile, software-controlled diagnostic ultrasound systems with on-screen display for thermal and mechanical values. It acquires ultrasound data and displays it in various modes (2-D, M-mode, Color Flow Doppler, Color M-mode, Color Power Angio, Pulsed Doppler).
• Predicate devices: ATL HDI 3000, ATL Ultramark® 9 HDI™, Atlantis Atlas 1.0, and Storz Renaissance A/B Scan.
• Technological characteristics: Uses piezo material in the transducer, similar to predicate devices, for transmitting and receiving sound waves. Biocompatible scanhead materials.
• Safety standards: Designed to meet IEC 601-1, UL 2601-1, C22.2 No. 601.1, CEI/IEC 1157:1992, and IEC 601-1-2.
• Intended use: Cardiac, peripheral vascular, fetal imaging, ophthalmic, and other general examinations (abdominal, pelvic, small parts, pediatric, prostate, neonatal cephalic, transcranial, biopsy guidance).
• Acoustic output limits: Specified for all applications other than ophthalmic and for ophthalmic applications, with values for ISPTA, TIS/TIB/TIC, Mechanical Index (MI), and Isppa. These limits are stated to be "same as predicate Track 3 devices."

Therefore, it is impossible to answer the specific questions related to AI device performance, acceptance criteria, and study details based on the provided document. The document primarily addresses the substantial equivalence of a new ultrasound hardware system to existing ones, focusing on safety, intended use, and acoustic output, not on the performance of a diagnostic algorithm or AI.

Ask a specific question about this device